Recall Z-0595-2018 ยท NSU Instrumentation For Clinical Multiplex Test Systems
Hologic, Inc
Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates all aspects of nucleic acid testing on a single, integrated platform. The Panther can be test samples with random access or batch managed; can perform multiple assays on the same patient sample with
| Date | Jan 20, 2018 |
| Status | Terminated |
| Reason | The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator. |
| Root cause | Device Design |
| Action | The firm sent an Urgent Medical Device Recall Notification dated January 8, 2018 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed that a Hologic representative will contact your site to arrange a visit in order to provide an interim solution to secure the glass panel until a replacement monitor with the issue corrected can be installed. For questions contact Hologic Technical Support. at +1-888-484-4747 or +1-858-410-8511 or by e-mail at molecularsupport@hologic.com |
| Quantity | 103 units |
| Distribution | Worldwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132251 | APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) Hologic / Gen-Probe Incorporated, Oct 17, 2013 |